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A Multiple Ascending Dose Study of GS 5885 in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01193478
Recruitment Status : Completed
First Posted : September 2, 2010
Last Update Posted : January 21, 2013
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
The primary purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and activity of escalating, multiple, oral doses of GS-5885 in subjects with chronic genotype 1 Hepatitis C Virus (HCV) infection. Each participant in the study will be sequestered in the clinic for the initial 5 days of the study.

Condition or disease Intervention/treatment Phase
HCV Infection Drug: GS-5885 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Escalating, Multiple, Oral Doses of GS 5885 in Treatment Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection
Study Start Date : August 2010
Primary Completion Date : January 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Cohort 1
GS-5885 (3 mg), once daily or matching placebo, once daily
Drug: GS-5885
tablet, oral, 3 mg once daily for 3 days
Drug: Placebo
tablet, oral, once daily for 3 days
Active Comparator: Cohort 2
GS-5885 (10 mg), once daily or matching placebo, once daily
Drug: GS-5885
tablet, oral, 10 mg once daily for 3 days
Drug: Placebo
tablet, oral, once daily for 3 days
Active Comparator: Cohort 3
GS-5885 (30 mg), once daily or matching placebo, once daily
Drug: GS-5885
tablet, oral, 30 mg once daily for 3 days
Drug: Placebo
tablet, oral, once daily for 3 days
Active Comparator: Cohort 4
GS-5885 ( up to 90 mg), once daily or matching placebo, once daily
Drug: GS-5885
tablet, oral, up to 90 mg once daily for 3 days
Drug: Placebo
tablet, oral, once daily for 3 days
Active Comparator: Cohort 5
GS-5885 (up to 90 mg), once daily or matching placebo, once daily
Drug: GS-5885
tablet, oral, up to 90 mg once daily for 3 days
Drug: Placebo
tablet, oral, once daily for 3 days
Active Comparator: Cohort 6 (optional)
GS-5885 (up to 90 mg), once daily or matching placebo, once daily
Drug: GS-5885
tablet, oral, up to 90 mg once daily for 3 days
Drug: Placebo
tablet, oral, once daily for 3 days



Primary Outcome Measures :
  1. Number of subjects reporting an adverse event or experiencing a laboratory abnormality [ Time Frame: Safety and tolerability assessments will be performed up to Study Day 14 following administration of multiple doses of GS-5885 or placebo for 3 days ]
  2. Antiviral activity measures: measured by change in plasma HCV RNA levels form baseline [ Time Frame: Assessed up to Study Day 14 following administration of multiple doses of GS-5885 or placebo for 3 days ]

Secondary Outcome Measures :
  1. Measure of GS-5885 plasma concentration over time [ Time Frame: Assessed up to Study Day 14 following administration of multiple doses of GS-5885 or placebo for 3 days ]
  2. Emergence of viral resistance [ Time Frame: Up to 48 weeks following Study Day 14 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronically infected with HCV genotype 1
  • HCV treatment-naïve
  • Not co-infected with HIV or HBV
  • HCV RNA viral load of at least 100,000 IU/mL
  • BMI 19 to 35 kg/m2
  • Subject agrees to use highly effective contraception methods if female of childbearing potential or sexually active male.

Exclusion Criteria:

  • History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
  • Decompensated liver disease or cirrhosis or evidence of hepatocellular carcinoma
  • Serological evidence of co-infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or another HCV genotype
  • Subjects with known, current use of amphetamines and/or cocaine; subjects taking methadone or buprenorphine (opioid replacement therapy) or ongoing alcohol abuse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01193478


Locations
United States, California
Anaheim, California, United States, 92801
Cypress, California, United States, 90630
National City, California, United States, 91950
United States, District of Columbia
Washington, District of Columbia, United States, 20010
United States, Florida
Deland, Florida, United States, 32720
Miami, Florida, United States, 33169
Orlando, Florida, United States, 32809
United States, Missouri
St. Louis, Missouri, United States, 63104
United States, Oregon
Portland, Oregon, United States, 97239
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19139
United States, Texas
Houston, Texas, United States, 77030
San Antonio, Texas, United States, 78215
United States, Washington
Tacoma, Washington, United States, 98418
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Diana Brainard, MD Gilead Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01193478     History of Changes
Other Study ID Numbers: GS-US-256-0102
First Posted: September 2, 2010    Key Record Dates
Last Update Posted: January 21, 2013
Last Verified: January 2013

Keywords provided by Gilead Sciences:
Hepatitis C
HCV RNA
multiple ascending dose
NS5A
GS-5885
chronic genotype 1 HCV infection

Additional relevant MeSH terms:
Infection
Hepatitis
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Ledipasvir
Antiviral Agents
Anti-Infective Agents